Reporting Ethical Aspects in Published Research Articles in the Indian Journal of Psychiatry

Article excerpt

Byline: Santosh. Chaturvedi, B. Somashekar

Background: Reporting of informed consent and ethical approval are important aspects of published papers which indicate the knowledge and sensitivity about ethical aspects of research by the researchers. Materials and Methods: This study reports description of informed consent and ethical approval in the published psychiatric research in the main journal of psychiatry in India. All original research articles (n=157) published in the Indian Journal of Psychiatry in the years 2000, 2003 to 2007 were included. Results: Informed consent was mentioned in 51% of studies in 2000, which gradually rose to 82% by the year 2007. Ethics committee approvals were mentioned in 2% of studies in 2000, and 25% of reports in 2007. Consent was reported to be written in only 40%, content of the consent forms was mentioned in 17%, and the language of consent form was reported in 3% of the studies where consent was reported. Conclusions: Regulation of ethical principles and formulation of necessary guidelines or rules for research as well as for publications are necessary and desirable to ensure the safety of participants and good quality of research.

Introduction

Almost all nations around the world are familiar with the concept of informed consent and ethical approvals, though the standards of their understanding and implementation differ. The system is paternalistic in some countries where the clinician takes decisions for patients and diametrically opposite, self-deterministic in others, which emphasize patient autonomy. Other countries may lie somewhere along the spectrum and appear heading towards the transparent model. It is a well-recognized principle in medical ethics that the consent of a patient should be obtained before performing any procedure whatsoever, whether it be invasive or noninvasive, for the purpose of research or for treatment. It has also been a legal requirement to conduct research. Informed consent is meaningful only when potential research subjects assess the relevant risk and benefits of proposed intervention and then voluntarily gives authorization to proceed.

Informed consent assumes more importance in psychiatric research due to issues related to competence of a person with psychiatric disorder to give consent, validity of the consent given by a patient with lack of insight or impaired judgment, and the proxy consent given by a relative or caregiver. Finally, one may question if it really is possible to obtain free and informed consent from a psychiatric patient with impaired judgment?

There is plenty of international literature on concerns regarding informed consent in psychiatric research, whether informed consent (for research or treatment) can be obtained from psychiatric patients, and how competency is established, however, there are very few reports from our country on different aspects of informed consent[sup] [1],[2],[3],[4],[5] competence.[sup] [6]

There has been a steady growth of psychiatric research in India. The leading journals all over the world proscribe a strict guideline to be followed in the conduct and publication of research. There are no studies, which have examined the issue of consent and ethical approval in the published psychiatric research in India. In this study, we attempted to examine whether informed consent and ethical approval were reported in the published psychiatric research in the Indian Journal of Psychiatry (IJP), the official journal published by Indian Psychiatric Society

Materials and Methods

All original research articles published in the Indian Journal of Psychiatry in the years 2000, 2003 to 2007 were included in the study. Research articles, which warrant consent such as drug trials, trials involving electroconvulsive therapy, studies involving invasive procedures and clinical interviews undertaken for research (not part of routine clinical assessment) were included in the assessment. …